The Supreme Court has declined to admit a writ petition filed by the All India Patent Officers’ Welfare Association (AIPOWA), which sought a court-monitored investigation and a probe by the Central Bureau of Investigation (CBI) into alleged unauthorized access and data leakage involving sensitive patent and trademark information.
A bench comprising Chief Justice of India Sanjiv Khanna and Justice Sanjay Kumar refused to entertain the petition under Article 32 of the Constitution. However, the Court allowed AIPOWA the liberty to approach the appropriate High Court under Article 226 for further remedies. The Court made it clear that it had not offered any opinion on the merits of the allegations or whether the petition should be admitted by the High Court.
The petition alleged that confidential data from the Indian Intellectual Property Offices (IPO) was improperly accessed and shared with Kaizen Institute, a private multinational consultancy, without following due legal and administrative procedures. According to AIPOWA, this access was facilitated by officials in the Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM) despite a lack of formal approval from the DPIIT.
The association claimed that Kaizen was allowed to operate within IPO premises based solely on internal email communications, which allegedly misrepresented its links to the Prime Minister’s Office and the Capacity Building Commission (CBC). In contrast, similar access was reportedly denied to a senior government officer.
The petition further argued that this arrangement breached multiple provisions of the Patents Act, 1970, and the Trade Marks Act, 1999. It contended that CGPDTM, being a subordinate office, had no authority to enter into such arrangements without explicit clearance from the Ministry of Commerce and Industry.
Additionally, AIPOWA criticized the process through which Kaizen was engaged, stating that no competitive bidding took place, violating public procurement rules and principles of transparency and accountability. The petition also highlighted an MoU signed among CGPDTM, the CBC, and the Centre for Effective Governance of Indian States (CEGIS), pointing to a clause that indicated CBC’s role in coordinating with Kaizen for process improvements at CGPDTM.
The petition had urged the Court to nullify the MoU, initiate a CBI investigation, and hold those responsible accountable under Indian laws and international agreements, including the Patent Cooperation Treaty and Madrid Protocol.
Senior Advocate Neeraj Kishan Kaul appeared on behalf of AIPOWA. While the Supreme Court declined to intervene directly, it left the door open for the matter to be taken up by a High Court.
High Court
Calcutta High Court Upholds Transparency and Fairness in Patent Examination: Takeda Pharmaceutical Co. Ltd. v. Controller of Patents
In a significant ruling that underscores the importance of transparency, reasoned decision-making, and procedural fairness in patent examination, the Calcutta High Court has set aside a refusal order issued by the Patent Office in the case of Takeda Pharmaceutical Co. Ltd. v. Controller of Patents and Designs & Ors. The Court found that the Patent Office’s failure to consider crucial post-filing data demonstrating technical advancement violated the principles of natural justice and remanded the matter for fresh consideration.
Facts of the Case
Takeda Pharmaceutical Co. Ltd. (“Takeda”) filed a patent application in 2010 for a novel class of protein kinase inhibitors intended for treating cancers associated with abnormal kinase activity. The application specifically claimed Brigatinib, a compound designed to selectively inhibit Anaplastic Lymphoma Kinase (ALK) over closely related kinases, including the insulin receptor (Ins-R). This selective inhibition was critical to Brigatinib’s therapeutic efficacy, as it reduced side effects that typically arise from off-target binding to Ins-R.
During the course of prosecution, Takeda submitted experimental data demonstrating Brigatinib’s enhanced selectivity for ALK, as evidenced by reduced IC50 values (the concentration needed to inhibit 50% of kinase activity). Additionally, Takeda provided expert affidavits, comparative data with other marketed drugs, and evidence of industrial acclaim to substantiate the compound’s technical advancement and superior efficacy.
Refusal Order by the Controller
Despite the supporting data, the Controller of Patents rejected Takeda’s application on three grounds:
Lack of Inventive Step under Section 2(1)(ja)
Non-patentability under Section 3(d) of the Patents Act, which prevents the patenting of mere derivatives of known substances unless they show significant improvement in therapeutic efficacy
Insufficiency of Disclosure under Section 10(4), alleging that Takeda had not adequately described the invention.
Furthermore, the Controller contended that the application lacked any evidence of technical advancement or enhanced efficacy at the time of filing the specification.
Arguments by Takeda
They argued that the Controller had disregarded supplementary data and expert affidavits that demonstrated Brigatinib’s superior selectivity and efficacy. Takeda claimed that the inventive step analysis was flawed, arguing that the Controller had used hindsight to select prior art compounds and had wrongly assumed that a minor structural modification (the sulfonyl-phosphoryl substitution) would not have a significant effect on the compound’s performance.
Takeda further pointed out that the Controller had failed to consider the post-filing data submitted during prosecution, which demonstrated Brigatinib’s enhanced selectivity for ALK over Ins-R, reducing off-target effects and improving the drug’s therapeutic profile. According to Takeda, the hasty rejection failed to account for the complexity and novelty of their invention.
Court’s Findings
The Calcutta High Court sided with Takeda, finding that the Controller’s refusal was unreasoned and erroneous. In its judgment, the Court emphasized that the inventive step must be assessed in the context of the entire invention, and prior art should not be merely compared to isolated features of the invention. The Court specifically noted that the mere presence of structurally similar elements in the prior art does not make an invention obvious. The invention must be evaluated as a whole, considering its technical merits and novel contributions.
The Court also found that the Controller had misinterpreted the concept of bioisosterism and failed to consider that Brigatinib’s modification—substituting a sulfonyl group with a phosphoryl group—was not obvious in the context of the prior art. It emphasized that there was no teaching in the prior art to modify the structure of TAE684 in the way required to produce Brigatinib, particularly with regard to selective inhibition between ALK and Ins-R.
Regarding the issue of technical advancement, the Court pointed out that Takeda had submitted critical data, including experimental results showing Brigatinib’s superior selectivity for ALK and reduced off-target effects. The Court noted that the Controller had improperly disregarded this data, which was directly relevant to proving therapeutic efficacy.
Key Legal Principles: Procedural Fairness and Transparency
The Court ruled that the Controller had violated the principles of natural justice by failing to adequately consider all material facts and evidence submitted by Takeda, including post-filing data. The Court emphasized that under Indian patent law, post-filing data demonstrating technical advancement is not prohibited and must be duly considered by the examining authorities.
Furthermore, the Court held that the refusal was not supported by adequate reasoning and that the Controller’s decision-making process lacked clarity and fairness. The judgment highlighted the need for a reasoned order, one that addresses all relevant factors and provides a comprehensive explanation of why certain evidence is accepted or rejected.
Conclusion
By setting aside the refusal order, the Court has provided a clear directive to the Patent Office to re-evaluate the application in light of all available evidence, including post-filing data, and to ensure that all parties are given an adequate opportunity to be heard.
The Court has also remanded the case to the Patent Office for fresh consideration, with a mandate to complete the process within three months from the date of communication of the order. This ruling not only benefits Takeda but also reinforces the importance of ensuring fairness and accountability in the patent grant process, particularly in high-stakes pharmaceutical and biotechnology patents.
Impact on Patent Law in India
This judgment is expected to have far-reaching implications for patent law practice in India, especially in complex patent cases involving pharmaceutical and biotechnology inventions. It reinforces the need for patent examiners to engage thoroughly with the evidence presented, ensuring that decisions are based on substantive and comprehensive analyses rather than superficial assessments. This decision could also encourage more transparency in the examination process, ultimately fostering an environment that supports innovation and fair competition in the Indian patent ecosystem.
Facts of the Case
Takeda Pharmaceutical Co. Ltd. (“Takeda”) filed a patent application in 2010 for a novel class of protein kinase inhibitors intended for treating cancers associated with abnormal kinase activity. The application specifically claimed Brigatinib, a compound designed to selectively inhibit Anaplastic Lymphoma Kinase (ALK) over closely related kinases, including the insulin receptor (Ins-R). This selective inhibition was critical to Brigatinib’s therapeutic efficacy, as it reduced side effects that typically arise from off-target binding to Ins-R.
During the course of prosecution, Takeda submitted experimental data demonstrating Brigatinib’s enhanced selectivity for ALK, as evidenced by reduced IC50 values (the concentration needed to inhibit 50% of kinase activity). Additionally, Takeda provided expert affidavits, comparative data with other marketed drugs, and evidence of industrial acclaim to substantiate the compound’s technical advancement and superior efficacy.
Refusal Order by the Controller
Despite the supporting data, the Controller of Patents rejected Takeda’s application on three grounds:
Lack of Inventive Step under Section 2(1)(ja)
Non-patentability under Section 3(d) of the Patents Act, which prevents the patenting of mere derivatives of known substances unless they show significant improvement in therapeutic efficacy
Insufficiency of Disclosure under Section 10(4), alleging that Takeda had not adequately described the invention.
Furthermore, the Controller contended that the application lacked any evidence of technical advancement or enhanced efficacy at the time of filing the specification.
Arguments by Takeda
They argued that the Controller had disregarded supplementary data and expert affidavits that demonstrated Brigatinib’s superior selectivity and efficacy. Takeda claimed that the inventive step analysis was flawed, arguing that the Controller had used hindsight to select prior art compounds and had wrongly assumed that a minor structural modification (the sulfonyl-phosphoryl substitution) would not have a significant effect on the compound’s performance.
Takeda further pointed out that the Controller had failed to consider the post-filing data submitted during prosecution, which demonstrated Brigatinib’s enhanced selectivity for ALK over Ins-R, reducing off-target effects and improving the drug’s therapeutic profile. According to Takeda, the hasty rejection failed to account for the complexity and novelty of their invention.
Court’s Findings
The Calcutta High Court sided with Takeda, finding that the Controller’s refusal was unreasoned and erroneous. In its judgment, the Court emphasized that the inventive step must be assessed in the context of the entire invention, and prior art should not be merely compared to isolated features of the invention. The Court specifically noted that the mere presence of structurally similar elements in the prior art does not make an invention obvious. The invention must be evaluated as a whole, considering its technical merits and novel contributions.
The Court also found that the Controller had misinterpreted the concept of bioisosterism and failed to consider that Brigatinib’s modification—substituting a sulfonyl group with a phosphoryl group—was not obvious in the context of the prior art. It emphasized that there was no teaching in the prior art to modify the structure of TAE684 in the way required to produce Brigatinib, particularly with regard to selective inhibition between ALK and Ins-R.
Regarding the issue of technical advancement, the Court pointed out that Takeda had submitted critical data, including experimental results showing Brigatinib’s superior selectivity for ALK and reduced off-target effects. The Court noted that the Controller had improperly disregarded this data, which was directly relevant to proving therapeutic efficacy.
Key Legal Principles: Procedural Fairness and Transparency
The Court ruled that the Controller had violated the principles of natural justice by failing to adequately consider all material facts and evidence submitted by Takeda, including post-filing data. The Court emphasized that under Indian patent law, post-filing data demonstrating technical advancement is not prohibited and must be duly considered by the examining authorities.
Furthermore, the Court held that the refusal was not supported by adequate reasoning and that the Controller’s decision-making process lacked clarity and fairness. The judgment highlighted the need for a reasoned order, one that addresses all relevant factors and provides a comprehensive explanation of why certain evidence is accepted or rejected.
Conclusion
By setting aside the refusal order, the Court has provided a clear directive to the Patent Office to re-evaluate the application in light of all available evidence, including post-filing data, and to ensure that all parties are given an adequate opportunity to be heard.
The Court has also remanded the case to the Patent Office for fresh consideration, with a mandate to complete the process within three months from the date of communication of the order. This ruling not only benefits Takeda but also reinforces the importance of ensuring fairness and accountability in the patent grant process, particularly in high-stakes pharmaceutical and biotechnology patents.
Impact on Patent Law in India
This judgment is expected to have far-reaching implications for patent law practice in India, especially in complex patent cases involving pharmaceutical and biotechnology inventions. It reinforces the need for patent examiners to engage thoroughly with the evidence presented, ensuring that decisions are based on substantive and comprehensive analyses rather than superficial assessments. This decision could also encourage more transparency in the examination process, ultimately fostering an environment that supports innovation and fair competition in the Indian patent ecosystem.
Landmark Delhi High Court Ruling Prioritizes Access to Life-Saving Drugs Over Patent Protection
In a powerful judgment that resonates with the ongoing global debate on healthcare access versus intellectual property rights, Justice Mini Pushkarna of the Delhi High Court has delivered a standout ruling that places public health and patient affordability at the heart of India’s patent law jurisprudence.
On March 24, 2025, the Court dismissed a patent infringement suit filed by Swiss pharmaceutical giant Hoffman-La Roche against Hyderabad-based Natco Pharma, in a case involving the prohibitively expensive spinal muscular atrophy (SMA) drug, risdiplam, marketed internationally as Evrysdi.
💊 The High Stakes: Life-Saving Medicine or Legal Monopoly?
Spinal muscular atrophy is a rare genetic disorder that progressively weakens muscles used for breathing, walking, and other vital functions. Risdiplam is the only approved oral treatment available in India for SMA, and its cost places it far out of reach for most patients. One bottle reportedly costs ₹6 lakh, with a typical patient requiring 30 bottles a year—a staggering ₹1.8 crore annually.
Natco Pharma has developed a generic version of risdiplam, challenging Roche’s patent rights. Roche, in response, approached the court to halt the sale of Natco’s version, claiming patent infringement and requesting an interim injunction.
⚖️ Justice Pushkarna’s Clear Stand: People First
In a firm and clear ruling, Justice Pushkarna refused the injunction, emphasizing that public health cannot be treated lightly. She wrote:
She also highlighted a critical point in patent law: while pharma companies can be compensated later through damages, there is no mechanism to compensate the public for a lack of access to essential medicine.
This case stands out because the voice of patients was directly heard in court. Two SMA patients intervened to share their lived experiences—stating unequivocally that they could not afford Roche’s drug and had no alternative treatment available.
💸 Big Pharma’s “Patient Assistance” Argument Falls Flat
Roche attempted to soften the blow by pointing to its Patient Assistance Programme (PAP)—an initiative that offers discounted medication to a limited number of patients. But the court saw through the strategy.
Justice Pushkarna called the program “far too limited” and noted that even the proposed reduced prices (revealed in a sealed cover) were insufficient to address widespread affordability. Only a fraction of patients could potentially benefit, leaving many out in the cold.
She also acknowledged budgetary limitations of the National Policy for Rare Diseases (NPRD)—a government scheme that provides up to ₹50 lakh per patient but has only been able to support 1,118 patients, despite India recognizing 63 rare diseases.
🔄 Global Implications & Legal Loopholes
Interestingly, this is not the only battleground for Roche and Natco. In the U.S., Natco is seeking approval to launch its generic risdiplam through an Abbreviated New Drug Application (ANDA), and is currently facing another infringement suit there. Despite being a rare disease drug, Evrysdi clocked $1.8 billion in U.S. sales in 2024, a growth of 18%, thanks to its user-friendly oral format.
Back in India, the patent debate hinges on Roche’s attempt to claim protection under a “species patent”, even though a broader “genus patent” had been filed earlier internationally. Natco argues that Roche is trying to extend its monopoly by segmenting patents, which is not allowed under Indian law if the new invention was already disclosed.
🧠 A Legal Shift in Priorities
The ruling isn’t just about one drug or one company. It signals a broader shift in judicial thinking, where courts are weighing public health more heavily in patent disputes, especially for essential or life-saving medicines.
This isn’t the first time Indian courts have leaned this way. In a 2008 case, Roche sought an injunction against Cipla over its cancer drug erlotinib (Tarceva). The court refused, noting that Cipla’s version was significantly cheaper, and the balance of convenience lay with affordable treatment.
🧬 What This Means for Patients and Policy
This case is likely to become a benchmark in how rare disease drugs are treated in Indian courts, especially when affordability is at stake. It also brings renewed focus on the inadequacy of current government schemes to support patients with ultra-expensive therapies.
For pharmaceutical companies, it’s a wake-up call: patent rights do not guarantee exclusivity if access is denied to the vast majority.
For patients, it is a glimmer of hope—an acknowledgment that their right to live cannot be outweighed by corporate profits.
📝 Final Thoughts
In Justice Pushkarna’s words, “There exists no right for the public to lessen or compensate itself.” This ruling flips the script, putting people before patents, and serves as a reminder that innovation must go hand in hand with access.
India has long been seen as the pharmacy of the developing world, and rulings like this ensure that mantle remains intact.